Senior Clinical Project Manager
New
United StatesFull-TimeSenior
Salary125,000 - 175,000 USD per year
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Job Details
- Experience
- 10+ years of experience in clinical research and development; at least 7 years of direct clinical project management experience.
- Required Skills
- BudgetingRisk ManagementStakeholder management
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Health Sciences, or a related field.
- 10+ years of experience in clinical research and development within a pharmaceutical, biotechnology, or CRO environment.
- At least 7 years of direct clinical project management experience across multiple phases of clinical trials.
- Strong knowledge of clinical trial processes including site selection, study start-up, monitoring, data management, regulatory submissions, and vendor management.
- Oncology clinical trial experience is required.
- Solid understanding of global regulatory frameworks including ICH, FDA, Health Canada, and EMA guidelines.
- Strong financial acumen with experience in budgeting, forecasting, and managing project profitability.
- Excellent leadership, communication, negotiation, and stakeholder management skills.
- Strong problem-solving abilities with the capacity to manage conflict and drive resolution in complex environments.
- Willingness to travel up to 20%, including internationally when required.
Responsibilities
- Lead the planning, execution, and delivery of Phase I–IV clinical trials, ensuring alignment with contractual scope, timelines, budgets, and regulatory requirements.
- Coordinate cross-functional teams including clinical operations, data management, biostatistics, regulatory, and vendors to ensure seamless project execution.
- Develop and maintain detailed project plans, including resource allocation, financial tracking, risk assessment, and mitigation strategies.
- Monitor project performance, track progress against milestones, and provide regular status updates to internal leadership and external sponsors.
- Manage client relationships, acting as the primary point of contact for project communication, issue resolution, and change order discussions.
- Ensure compliance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory standards throughout the project lifecycle.
- Identify and escalate project risks, resource gaps, or scope changes while ensuring timely corrective actions and resolution.
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